FDA Orange Book
Generic for Triphasil-28
Triphasil-28 contains levonorgestrel and ethinyl estradiol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Triphasil-28 is levonorgestrel and ethinyl estradiol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Triphasil-28 products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral-28 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG | Discontinued | None | 4 | AB |
NDA 019190, held by WYETH PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levonorgestrel and ethinyl estradiol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 074538 | AB (A-rated, therapeutically equivalent) | December 18, 1997 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
| DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC | 075809 | AB (A-rated, therapeutically equivalent) | July 16, 2001 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
| NOVAST LABORATORIES LTD | 090719 | AB (A-rated, therapeutically equivalent) | December 29, 2010 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
| LUPIN LTD | 200248 | AB (A-rated, therapeutically equivalent) | November 19, 2015 | 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG |
Questions
Is there a generic for Triphasil-28?
Yes. The generic name for Triphasil-28 is levonorgestrel and ethinyl estradiol. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Triphasil-28?
The active ingredient in Triphasil-28 is levonorgestrel and ethinyl estradiol, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.